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DementiaPLAN-HomeNCT05225818

Preparing Successful Aging Through Dementia Literacy Education And Navigation (PLAN)-Home

A study testing PLAN - Home in people with Dementia, run by Johns Hopkins University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Rapid growth in elderly population and higher prevalence of dementia necessitates further attention to dementia. Even though early detection and continuing care are mainstays of dementia care, limited access to dementia diagnosis and dementia care planning for elders could be attributed to factors like low dementia… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia
What is being tested?
PLAN - Home
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 31 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Age 65 years or older
  • Enrolled in home-based primary care
  • Mini-Mental State Exam (MMSE) <24
  • Has a caregiver who lives in the same household or has at least weekly interactions
  • Able to consent or has a proxy available for consent
  • Written consent to participate in the study
Show all 10Show fewer
  • Age 18 years or older
  • Able to read, write, and speak English
  • Lives in the same household with an older adult with MMSE <24 or has at least weekly interactions
  • Written consent to participate in the study

Who cannot join

  • Previous dementia diagnosis
  • All Axis I diagnoses other than depressive disorders (e.g., schizophrenia, bipolar disorder, or substance use disorder)
  • Neurological disorders other than Alzheimer's disease that might affect cognition (e.g., stroke)
  • Use of psychotropic drugs including antipsychotics
  • Plan to move from the area within 6 months
  • Active treatment for a terminal illness or in hospice

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Johns Hopkins University

    Baltimore, Maryland, 21218

Other trials in United States

About this study

Official title: Preparing Successful Aging Through Dementia Literacy Education And Navigation (PLAN)-Home Pilot

Rapid growth in elderly population and higher prevalence of dementia necessitates further attention to dementia. Even though early detection and continuing care are mainstays of dementia care, limited access to dementia diagnosis and dementia care planning for elders could be attributed to factors like low dementia literacy-the capacity to obtain, process, and understand basic dementia-related information and services to make appropriate health decisions-and lack of social support. Developing innovative pathways to transition families of individuals with probable dementia into healthcare access for early diagnosis of dementia and timely dementia care planning can benefit patients and the patients' families. To this end, the investigators' study aims are to develop a home-based intervention program for dementia evaluation, education, and care planning and test its feasibility and acceptability in a pilot study.

Read the detailed description

This research is being done to understand how an education and navigation support program led by trained Nurse Practitioners (NPs) helps older adults with probable dementia and the patients' caregivers. In a 2-arm randomized controlled trial (RCT) with 40 dyads, the investigators' aims are to (1) test the effect of a community-based intervention delivered by trained NPs for undiagnosed older adults with probable dementia and the patients' caregivers, (2) evaluate the effect of the PLAN on improving caregiver's dementia literacy, self-efficacy in dementia care and service use, social support, depression, and quality of life at 6 months in comparison to a group of participants who receive a copy of the publicly available educational material, and (3) examine whether the effect of PLAN differs across age, sex, and education caregiver subgroups.

Aim 1 tests the following hypotheses: older adults with probable dementia who receive the PLAN will have higher rates of linkage to medical service for dementia than those in the control group. Aim 2 tests the following hypothesis: caregivers in the PLAN group will have higher dementia literacy, self-efficacy in dementia care and service use, social support, and quality of life, and lower depression than those in the control group.

Conditions
Dementia
Being tested
PLAN - Home
Keywords
Nurse Practitioners, Diagnosis, Social Support, Patient Education
Medical subject headings
Dementia, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLAN - HomeBehavioural

    home-based intervention program for dementia evaluation, education, and care planning

Study groups in NCT05225818
Study groupRoleWhat they receive
Experimental: PLAN - HomeExperimentalTrained NPs will deliver the PLAN-Home to the enrolled participants, which consists of home-based dementia evaluation, education, and care planning for older adults with probable dementia.
Receives: Behavioral: PLAN - Home
No intervention: Control GroupNo interventionThe control group will receive a copy of the publicly available educational material on 10 warning signs and symptoms of Alzheimer's disease and action steps prepared by Alzheimer's Association.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants linked to medical service for dementia

    Number of participants linked to medical service for dementia measured by medical record verification. Linkage to medical service for dementia is defined as having had primary care or specialty care provider evaluation for cognitive impairment.

    Measured: 6 months

Secondary outcomes (11)

  1. Number of participants who complete a plan for dementia care

    Completion of a plan for dementia care is measured by study questionnaire: "yes" or "no".

    Measured: 6 months

  2. Number of participants who complete advanced directives

    Completion of advanced directives is measured by study questionnaire: "yes" or "no".

    Measured: 6 months

  3. Change in functional ability for activities of daily living as assessed by Katz scores

    The Katz Index of Independence in Activities of Daily Living is a 7-item instrument, with 1 point assigned for each item respondents are able to perform independently without supervision, direction, or guidance. Scores range from 0 to 6 with higher scores indicating higher independence.

    Measured: Baseline and 6 months

  4. Change in functional ability for instrumental activities of daily living as assessed by Lawton-Brody scores

    The Lawton-Brody Instrumental Activities of Daily Living Scale is an 8-domain instrument (5 domains historically used for men), with 1 point assigned for each statement that reflects higher levels of functioning. Summary scores range from 0 to 8 (5 for men) with higher scores indicating higher functioning and independence.

    Measured: Baseline and 6 months

  5. Change in Patient quality of life as assessed by Quality of Life-Patient scores (for all patient participants)

    QoL-dementia older adult is a 13-item instrument and scoring ranges from "poor" coded as 1 to "excellent" coded as 4 for each item. Total scores will range from 13 to 52 with higher scores indicating higher quality of life.

    Measured: Baseline and 6 months

  6. Change in Dementia Literacy as assessed by Rapid Estimate of Adult Literacy in Medicine (REALM)-Dementia scores (for all caregiver participants)

    The dementia literacy test is a 11-item instrument. Scoring of the dementia literacy instrument is in such a way that each correct response will be coded as 1 whereas incorrect response will be coded as 0. Total scores can range from 0 to 11 with higher scores indicating higher dementia literacy.

    Measured: Baseline and 6 months

  7. Change in Social Support as assessed by Medical Outcomes Study (MOS)-Social Support survey scores (for all caregiver participants)

    The 8-item scale of medical outcomes study scoring ranges from "none of the time" coded as 1 to "all of the time" coded as 5 for each item. Total scores will range from 8 to 40 with higher scores indicating higher social support.

    Measured: Baseline and 6 months

  8. Change in depression as assessed by Patient Health Questionnaire-2 (for all caregiver participants)

    Patient health questionnaire-2 is a 2-item instrument and scoring ranges from "not at all" coded as 0 to "nearly every day" coded as 3. Total scores will range from 0 to 6 with higher score indicating greater depressive symptoms.

    Measured: Baseline and 6 months

  9. Change in self-efficacy as assessed by Self-Efficacy Dementia Scale scores

    Dementia self-efficacy scale is a 10-item instrument. Scoring of the dementia self-efficacy scale ranges from "not at all certain" coded as 1 to "very certain" coded as 10 for each item. Total scores will range from 10 to 100 with higher scores indicating higher self-efficacy.

    Measured: Baseline and 6 months

  10. Change in Caregiver Quality of Life

    QoL-dementia caregiver is a 13-item instrument and scoring ranges from "poor" coded as 1 to "excellent" coded as 4 for each item. Total scores will range from 13 to 52 with higher scores indicating higher quality of life.

    Measured: Baseline and 6 months

  11. Program satisfaction as assessed by study questionnaire

    Caregiver satisfaction with the intervention program will be measured on a 10-point visual analogue scale, with scoring ranges from 0 "not at all satisfied" to 10 "extremely/highly satisfied". Higher scores will indicate greater satisfaction with program.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start1 Jun 2022 (estimated)
  3. Primary completion31 Mar 2024 (estimated)
  4. Study completion31 Mar 2024 (estimated)

Why it stopped: Our study design changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05225818
Sponsor's protocol ID
IRB00299252
Acronym
PLAN-Home
Status last verified
Jun 2022
First submitted
24 Jan 2022
Last updated
1 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Robinson L, Tang E, Taylor JP. Dementia: timely diagnosis and early intervention. BMJ. 2015 Jun 16;350:h3029. doi: 10.1136/bmj.h3029. No abstract available.

    PubMed 26079686

  • Landers S, Madigan E, Leff B, Rosati RJ, McCann BA, Hornbake R, MacMillan R, Jones K, Bowles K, Dowding D, Lee T, Moorhead T, Rodriguez S, Breese E. The Future of Home Health Care: A Strategic Framework for Optimizing Value. Home Health Care Manag Pract. 2016 Nov;28(4):262-278. doi: 10.1177/1084822316666368. Epub 2016 Oct 5.

    PubMed 27746670

  • Vespa J. (March 13, 2018). The graying of America: More older adults than kids by 2035. United States Census Bureau. Retrieved from https://www.census.gov/library/stories/2018/03/graying-america.html.

  • Centers for Medicare & Medicaid Services. (February 06, 2019). New app displays what original Medicare covers. Retrieved from https://www.cms.gov/newsroom/press-releases/new-app-displays-what-original-medicare-covers#:~:text=The%20Medicare%20population%20is%20projected,almost%20daily%20(65%20percent).

  • Yao NA, Rose K, LeBaron V, Camacho F, Boling P. Increasing Role of Nurse Practitioners in House Call Programs. J Am Geriatr Soc. 2017 Apr;65(4):847-852. doi: 10.1111/jgs.14698. Epub 2016 Dec 28.

    PubMed 28029709

  • Keenan TA. (November 2010). Home and community preferences of the 45+ population. AARP Research. Retrieved from http://www.aarp.org/research/topics/community/info-2014/home-community-services-10.html.

  • Ng T, Harrington C, Musumeci M, Reaves EL. (November 3, 2015). Medicaid home and community-based services programs: 2012 data update. Kaiser Family Foundation. https://www.kff.org/medicaid/report/medicaid-home-and-community-based-services-programs-2012-data-update/.

  • Prasad S, Dunn W, Hillier LM, McAiney CA, Warren R, Rutherford P. Rural geriatric glue: a nurse practitioner-led model of care for enhancing primary care for frail older adults within an ecosystem approach. J Am Geriatr Soc. 2014 Sep;62(9):1772-80. doi: 10.1111/jgs.12982.

    PubMed 25243682

  • Jaffe S. Home Health Care Providers Struggle With State Laws And Medicare Rules As Demand Rises. Health Aff (Millwood). 2019 Jun;38(6):981-986. doi: 10.1377/hlthaff.2019.00529. No abstract available.

    PubMed 31158027

  • Maryland Health Care Commission. Home Health Utilization Tables and Agency Data Collection. Table 13: Total Number of Clients (Unduplicated Count) by Jurisdiction of Residence, Payment Source and Agency, Fiscal Year 2008. 2020 [cited 2021 November 19]. Available from https://mhcc.maryland.gov/public_use_files/index.aspx.

  • Maryland Health Care Commission. Home Health Utilization Tables and Agency Data Collection. Table 13: Total Number of Clients (Unduplicated Count) by Jurisdiction of Residence, Payment Source and Agency, Fiscal Year 2018. 2020 [cited 2021 November 19]. Available from https://mhcc.maryland.gov/public_use_files/index.aspx.

  • Osakwe ZT, Aliyu S, Sosina OA, Poghosyan L. The outcomes of nurse practitioner (NP)-Provided home visits: A systematic review. Geriatr Nurs. 2020 Nov-Dec;41(6):962-969. doi: 10.1016/j.gerinurse.2020.07.001. Epub 2020 Jul 24.

    PubMed 32718756

  • Wolff-Baker D, Ordona RB. The Expanding Role of Nurse Practitioners in Home-Based Primary Care: Opportunities and Challenges. J Gerontol Nurs. 2019 Jun 1;45(6):9-14. doi: 10.3928/00989134-20190422-01.

    PubMed 31135933

  • Echeverry LM, Lamb KV, Miller J. Impact of APN Home Visits in Reducing Healthcare Costs and Improving Function in Homebound Heart Failure. Home Healthc Now. 2015 Nov-Dec;33(10):532-7. doi: 10.1097/NHH.0000000000000304.

    PubMed 26529444

  • Coppa D, Winchester SB, Roberts MB. Home-based nurse practitioners demonstrate reductions in rehospitalizations and emergency department visits in a clinically complex patient population through an academic-clinical partnership. J Am Assoc Nurse Pract. 2018 Jun;30(6):335-343. doi: 10.1097/JXX.0000000000000060.

    PubMed 29878967

Questions about this trial

What is this clinical trial studying?

A study testing PLAN - Home in people with Dementia, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants linked to medical service for dementia (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05225818, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.

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